NCT07432724

Brief Summary

This study is conducted to evaluate the 18-month clinical performance of complete bioactive restorative system for occlusal restorations between diabetic and non-diabetic patients.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
20mo left

Started Aug 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Aug 2026Apr 2028

First Submitted

Initial submission to the registry

February 18, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 25, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

February 25, 2026

Status Verified

January 1, 2026

Enrollment Period

1.5 years

First QC Date

February 18, 2026

Last Update Submit

February 24, 2026

Conditions

Diabetes Mellitus (DM)

Keywords

Bioactive composite

Outcome Measures

Primary Outcomes (1)

  • Marginal discoloration

    Measuring device: Modified USPHS criteria

    T0: Baseline T1: 6 months T2: 12 months T3: 18 month

Secondary Outcomes (1)

  • Marginal adaptation, color match, secondary caries, Retention, wear, and postoperative sensitivity.

    T0: baseline T1: 6 months T2: 12 months T3: 18 months

Study Arms (2)

diabetic patients

EXPERIMENTAL
Other: bioactive composite

Non diabetic patients

EXPERIMENTAL
Other: bioactive composite

Interventions

bioactive compositeOTHER

the bioactive component present in the composite restoration.

Non diabetic patientsdiabetic patients

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients indicated for a Class I posterior composite restoration
  • permanent tooth
  • ICDAS 3 or 4

You may not qualify if:

  • uncontrolled diabetic patients
  • primary dentition
  • special needs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Rania Mosallam, Professor

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Sara Mohamed Manaa, PhD

CONTACT

00201022484815sara.mohamed.manaa@hotmail.com

yomna sayed, lecturer

CONTACT

00201006781076yomna.sayed@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

February 18, 2026

First Posted

February 25, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

April 1, 2028

Last Updated

February 25, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share